BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMACARRIER II SKIN GRAFT CARRIER, 1.5:1

    MDR report key: 3874625 · Received April 24, 2014

    Report

    Report Number
    1526350-2014-00323
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING THE GRAFT IN THE DERMACARRIER II SKIN GRAFT CARRIER, THE GRAFT GOT CRANKED AND CAME OUT SHREDDED. NO ADD'L CLINICAL INFO WAS REC'D PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248376 DERMACARRIER II SKIN GRAFT CARRIER, 1.5:1 DERMACARRIER II SKIN GRAFT CARRIER, 1.5:1 GFD ZIMMER SURGICAL NA 6251783

    Patients

    Seq Age Sex Outcome Treatment
    1